Scandinavian Diverticulitis Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study is to determine whether laparoscopic lavage changes the rate of severe complications in patients with acute perforated diverticulitis who traditionally are treated with primary resection.

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Detailed Description

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Acute diverticulitis is a common disease in the western world. Perforation of the acute diverticulitis with peritonitis is a feared complication and standard treatment (primary sigmoid resection such as Hartmann's procedure) still has unsatisfactory results. Both mortality and morbidity are quite high. Several uncontrolled trials have reported a lower mortality and morbidity when acute perforated diverticulitis is treated with laparoscopic lavage instead of radical surgery. The investigators wish to conduct a randomized multicenter trial in Scandinavia in order to compare the rates of severe postoperative complications in acute perforated diverticulitis if treated by traditional primary sigmoid resection or by laparoscopic lavage. The investigators are planning to include all patients admitted to the participating hospitals with clinical and radiological findings of acute perforated diverticulitis.

Conditions

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Diverticulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic lavage

Group Type ACTIVE_COMPARATOR

Surgery for acute perforated diverticulitis

Intervention Type PROCEDURE

Primary resection vs laparoscopic lavage

Primary resection

Group Type ACTIVE_COMPARATOR

Surgery for acute perforated diverticulitis

Intervention Type PROCEDURE

Primary resection vs laparoscopic lavage

Interventions

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Surgery for acute perforated diverticulitis

Primary resection vs laparoscopic lavage

Intervention Type PROCEDURE

Other Intervention Names

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Hartmann's procedure Acute diverticulitis Laparoscopic lavage Primary resection

Eligibility Criteria

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Inclusion Criteria

* age over 18
* clinical suspicion of perforated diverticulitis with indication for urgent surgery
* CT scan with free air and findings suggesting diverticulitis
* patient tolerates general anaesthesia
* patients written consent